BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 25112597 · Received May 7, 2026

    Report

    Report Number
    2243441-2026-00022
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    November 13, 2025
    Report Date
    May 7, 2026
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    QYM
    UDI-DI
    05413206251223
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT HAD A SERIOUS BLINDING ISSUE REGARDING THE VABYSMO PFS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141917 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V NF-3013RBKE05M 2412006 05413206251223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SYRINGE (FOR PRODUCT VABYSMO)